Clinical Results

Apitox Was Rigorously Evaluated in a Phase 3 Trial

A Phase 3, multi-center, randomized, double-blind, parallel-group clinical trial evaluating Apitox in subjects with knee osteoarthritis

Key inclusion criteria

  • Kellgren-Lawrence radiograph grade 1-3

  • Score ≥2 on question no. 1 of WOMAC

  • Use of chronic pain medication ≥4 days/week in the 28 days before screening

Key exclusion criteria

  • Hypersensitivity to bee venom

  • Positive skin test to bee venom

  • Intraarticular hyaluronic acid, corticosteroids, or Synvisc

  • Use of β-blockers, chronic oral antihistamines, or cytochrome P450 inhibitors

  • Concurrent inflammation or injury to target knee

Primary endpoint

  • Absolute change in WOMAC pain subscale score from baseline to Week 15

Secondary endpoint

  • Absolute change in WOMAC physical function subscale score from baseline to Week 15

WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Conrad VJ, et al. J Altern Complement Med. 2019;25(8):845-855.

Apitox Was Significantly More Efficacious Than Control Treatment at Week 15 and Through Week 19​

Change from baseline in ​WOMAC 
pain score​

Change from baseline in ​WOMAC physical function score​

Line graph of mean change from baseline at weeks 15, 17, and 19, with Apitox (-20.7) vs. Control (-17.6) at week 15 (secondary endpoint), showing statistical significance (p=0.0292, p=0.0342, p=0.1006).

Patient global assessment of knee osteoarthritis condition (Week 15)​

Stacked bar chart of patient response for Apitox (20.9% "Very Good," 61.1% "Good") vs. Control (23.3% "Very Good," 39.1% "Good"), showing a significant difference (p=0.0001).
key icon

Efficacy outcomes achieved by Apitox at Week 15 were comparable to than those achieved with Synvisc-One, an FDA-approved hyaluronan viscosupplement intraarticular injection​.

WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Conrad VJ, et al. J Altern Complement Med. 2019;25(8):845-855.​

Apitox Demonstrated Efficacy Across All Grades of Knee Osteoarthritis Severity

Rate of WOMAC physical function score response (Week 15)

≥40% improvement

≥60% improvement

Patient response rates to Apitox and control treatments across Grades 1, 2, and 3, indicating Apitox response rates of 64.4%, 69%, and 42.5%, compared to control rates of 23.7%, 39.7%, and 43.6%.
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All grades of knee osteoarthritis showed greater rates of clinical response in the Apitox arm at Week 15, including higher-severity patients who are the most likely candidates for knee replacement surgery.

WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index
Apimeds Pharmaceuticals. Data on file.